Aastrom Biosciences Announces First Patient Enrolled in REVIVE Phase 3 Clinical Trial of Ixmyelocel-T
May 09 2012 - 5:12PM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific expanded multicellular therapies for the treatment
of severe chronic cardiovascular diseases, today announced that the
first patient has been enrolled in the REVIVE Phase 3 clinical
trial of ixmyelocel-T. The REVIVE study is currently underway in
the United States to assess the efficacy and safety of ixmyelocel-T
in the treatment of no option patients with critical limb ischemia
(CLI).
The REVIVE trial is the largest randomized, double-blind,
placebo-controlled, multicenter study ever conducted in patients
with CLI. The Phase 3 trial has 80 treatment centers qualified
to enroll patients and will include 594 CLI patients who have no
option for revascularization and also have existing tissue loss due
to ischemia. Patients will be followed for a total of 18
months, including 12 months from randomization for efficacy and an
additional six months for safety. The primary endpoint of the
trial will be amputation-free survival at 12 months.
"The enrollment of the first patient in the REVIVE clinical
trial represents another important milestone in our effort to
advance the development program for ixmyelocel-T through the final
stages of clinical development. We are grateful to our
investigators for their commitment to enrolling patients as quickly
as possible in this important trial," said Tim Mayleben, president
and chief executive officer at Aastrom Biosciences.
For more information about the REVIVE trial, please visit
www.revivecli.com.
About Aastrom Biosciences
Aastrom Biosciences is the leader in developing
patient-specific, expanded multicellular therapies for use in the
treatment of patients with severe, chronic cardiovascular
diseases. The company's proprietary cell-processing technology
enables the manufacture of ixmyelocel-T, a patient-specific
multicellular therapy expanded from a patient's own bone marrow and
delivered directly to damaged tissues. Aastrom has advanced
ixmyelocel-T into late-stage clinical development, including a
Phase 3 clinical program to study patients with critical limb
ischemia and a planned Phase 2b clinical trial in patients with
ischemic dilated cardiomyopathy. For more information, please visit
Aastrom's website at www.aastrom.com. For more information on
the pivotal REVIVE Phase 3 clinical trial, please visit the trial
website at www.revivecli.com.
The Aastrom Biosciences, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3663
This document contains forward-looking statements, including,
without limitation, statements concerning clinical trial plans and
progress, objectives and expectations, clinical activity timing,
intended product development, the performance and contribution of
certain individuals and expected timing of collecting and analyzing
treatment data, all of which involve certain risks and
uncertainties. These statements are often, but are not always, made
through the use of words or phrases such as "anticipates,"
"intends," "estimates," "plans," "expects," "we believe," "we
intend," and similar words or phrases, or future or conditional
verbs such as "will," "would," "should," "potential," "could,"
"may," or similar expressions. Actual results may differ
significantly from the expectations contained in the
forward-looking statements. Among the factors that may result in
differences are the inherent uncertainties associated with clinical
trial and product development activities, regulatory approval
requirements, competitive developments, and the availability of
resources and the allocation of resources among different potential
uses. These and other significant factors are discussed in greater
detail in Aastrom's Annual or Transition Report on Form 10-K or
10-K/T, Quarterly Reports on Form 10-Q and other filings with the
Securities and Exchange Commission. These forward-looking
statements reflect management's current views and Aastrom does not
undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this release except as required by law.
CONTACT: Media contact
Andrea Coan
Berry & Company
acoan@berrypr.com
(212) 253-8881
Investor contact
Danielle Spangler
The Trout Group
dspangler@troutgroup.com
(646) 378-2924
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